Inventiva: launch of a clinical study in Japan

(CercleFinance.com) - Inventiva announced Thursday evening the launch in Japan of a clinical development program for Lanifibranor, its most advanced drug candidate, in the treatment of MASH, a liver disease.


The biopharmaceutical company, which specializes in the clinical development of orally-administered small molecules, reports the inclusion of its first participant in a Phase 1 study.

This trial is designed to assess the product's safety, tolerability, pharmacokinetics and pharmacodynamics.

In this single-center study, 32 subjects will be randomized into four cohorts and will receive Lanifibranor for 14 days once daily.

The study is part of the exclusive license agreement signed in 2023 between Inventiva and Hepalys to develop and commercialize Lanifibranor in Japan and South Korea.

Under the terms of the agreement, Hepalys is responsible for conducting and financing all trials in Japan and South Korea required to file a marketing authorization application in these territories.

Inventiva argues that positive results could support the launch of a pivotal Phase 3 study in patients with MASH, a disease which affects up to 2.7% of the Japanese population according to its estimates.

Following these announcements, Inventiva's share price climbed by over 7% on Friday morning on the Paris Bourse, bringing its gains since the start of the year to almost 18%.

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